K233106 is an FDA 510(k) clearance for the AccuCath Ace™ Intravascular Catheter. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Bard Access Systems, Inc. (C.R. Bard, Inc.) (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 19, 2024, 205 days after receiving the submission on September 27, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K233106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | April 19, 2024 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |